Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996255
Recruitment Status : Terminated
First Posted : October 16, 2009
Last Update Posted : October 16, 2009
Information provided by:
Nerviano Medical Sciences

October 14, 2009
October 16, 2009
October 16, 2009
November 2006
February 2008   (Final data collection date for primary outcome measure)
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ]
Same as current
No Changes Posted
  • Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ]
  • Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters. [ Time Frame: First 2 cycles ]
  • Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment. [ Time Frame: First cycle ]
Same as current
Not Provided
Not Provided
Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors
A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors
The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced/Metastatic Solid Tumors
Drug: PHA-793887
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.
Experimental: Dose-Escalation
Intervention: Drug: PHA-793887
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced/metastatic solid tumors for which no standard therapy exists
  • ECOG (WHO) performance status 0-1
  • Life expectancy of at least 3 months
  • Age ≥ 18 years
  • Adequate liver, pancreas and renal function
  • Acceptable hematologic status
  • Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1
  • Treatment with surgery, chemotherapy, or investigational therapy must be completed at least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin C and liposomal doxorubicin)
  • Prior radiation therapy allowed in no more than 25% of bone marrow reserve
  • Men and women of child-producing potential must agree upon the use of effective contraceptive methods

Exclusion Criteria:

  • In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
  • Known brain metastases
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Pregnant or breast feeding women
  • Known infection with HIV, active hepatitis B or hepatitis C
  • Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation
  • History of pancreatitis or disorders making the patient at risk of pancreatitis
  • Previous history or current presence of neurological disorders
  • Patients with pre-existing symptoms of peripheral neuropathy not related to prior anticancer therapy(ies)
  • Concomitant treatment that may be associated with peripheral neuropathy
  • Other severe concurrent conditions that could compromise protocol objectives.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
EudraCT Number: 2006-002149-35
Not Provided
Not Provided
Clinical Research Head, Nerviano Medical Sciences
Nerviano Medical Sciences
Not Provided
Principal Investigator: Jean-Charles Soria, MD Professor Institut Gustave-Roussy, Villejuif Cedex, France
Principal Investigator: Chris Twelves, MD Professor St James University Hospital, Leeds, UK
Nerviano Medical Sciences
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP